21 CFR 1107.58
§ 1107.58 Record retention.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1107.58, § 1107.58 Record retention, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91527
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Full text
Each applicant that receives an order under § 1107.46 authorizing the marketing of a new tobacco product must maintain all records required by this subpart and that support the SE Report for a substantial equivalence order. These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. All records must be retained for a period of not less than 4 years from the date of the order even if such product is discontinued.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.